MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD OFFSET CUP INTRODUCER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 90128275

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

It was reported that the item was found broken while outside the patient.No delay reported.No patient injuries reported.An s&n backup was available.

Manufacturer Narrative

H3, h6: an offset cup introducer (90128275, 3446822) was returned for investigation.It was reported that the item was found broken while outside the patient.A review of the complaint history for the offset cup introducer was performed using part and batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.The production records were reviewed for the devices reportedly involved in this incident.The released devices involved met manufacturing specifications at the time of production.Non-conformance was identified for the rejected devices.There are visible marks and scratches across the device, consistent with surgical use.Drive chain mechanism is broken.A functional evaluation is not required as the part was confirmed to be broken.This confirms the reported complaint.It is unknown how many cycles the instrument has been through over it's 3+ years lifespan.Based on the available information, the proposed probable root cause for the failure is improper routine maintenance.Smith and nephew recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No preventative or corrective action has been initiated as a result of this investigation.The device cannot be repaired and will be retained.

• Brand Name: OFFSET CUP INTRODUCER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11282126
• MDR Text Key: 244897726
• Report Number: 3005975929-2021-00072
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010591531
• UDI-Public: 03596010591531
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90128275
• Device Catalogue Number: 90128275
• Device Lot Number: 3446822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1